Debiopharm X is an independent biopharmaceutical company based in Switzerland. Primarily active in oncology and infectious diseases, Debiopharm X aims to improve health and the quality of life. Debiopharm Research & Manufacturing SA, based in Martigny, is a pharmaceutical research, development, and manufacturing company compliant with Good Manufacturing Practices and certified by major regulatory authorities. As the group's center of expertise in therapeutic chemistry, the company is the world leader in injectable products based on poly(lactic-co-glycolic acid) (PLGA). To strengthen its Industrial Transposition department, Debiopharm X is looking for a Senior Analytical Project Manager.Your Mission:Manage analytical projects within the CMC X Industrial department, whose mission is to develop and industrialize pharmaceutical products from the beginning of clinical phases until commercialization and ensure the life cycle management of marketed products through analytical project plans integrating the necessary technical-regulatory requirements depending on the phase of development and coordinate/supervise activities in accordance with these plans, while respecting the quality, deadlines, and announced costs.Your Responsibilities:Establish and lead the development of analytical project plans within multidisciplinary teams including experts in process development, injection device development, toxicology, etc. Supervise the transfer and validation of analytical methods (liquid chromatography, dissolution tests, etc.) primarily for peptides/formulated peptide products, the execution of stress and forced degradation tests, robustness tests, and provide support for the development and validation of manufacturing processes and primary containers, including providing expertise in risk analyses related to these activities. Participate in setting up specifications for raw materials, intermediates, and finished products. Participate in the writing of regulatory dossiers and various CMC documents. Manage analytical activities outsourced to CRO/CDMO X in collaboration with these external partners. Supervise the implementation of new methodologies by establishing the Analytical Quality By Design (AQBD).Your Profile:PhD in analytical chemistry or equivalent, with a minimum of 5 to 10 years of experience in analytical development, in the pharmaceutical industry or as a project manager in academia. Experience in the field of peptides, particularly with radioligand precursors, would be a plus. Previous experience in project management, ideally with ongoing projects and in a dynamic environment. Strong knowledge of regulatory guidelines related to proactive development, with a willingness to continually improve. Ability to balance risks associated with a project, especially quality, while demonstrating effectiveness and efficiency. Ability to synthesize and convey information effectively, both orally and in writing, especially in communication with health authorities. Proficiency in French and English. jidc547a6daen jit0206aen jpiy26aen